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Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 1
Licensed Manufacturers in Hong Kong
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong
Version 4.3
Pharmacy and Poisons Board of Hong Kong
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 2
Licensed Manufacturers in Hong Kong
Contents
Contents ................................................................................................................ 2
1. Background ................................................................................................... 3
2. Purpose of this Guidance .............................................................................. 4
3. Scope ............................................................................................................. 4
4. Authorized Person for Pharmaceutical Manufacturers ................................. 5
Registration as an AP for Pharmaceutical Manufacturers ....................................................... 5 Additional Requirements for Release of Pharmaceutical Products Requiring Special Attention 6
5. Authorized Person for ATP Manufacturers ................................................... 7
Registration as an AP for ATP Manufacturers .......................................................................... 7 Additional Requirements for Release of ATPs .......................................................................... 8
6. Authorized Person for Secondary Packaging Manufacturers ....................... 9
Registration as an AP for Secondary Packaging Manufacturers (i.e. Quality Assurance Officer) ...................................................................................................................... 9
7. Other Key Personnel ................................................................................... 11
Head of Production and Head of Quality Control for Pharmaceutical Manufacturers ......... 11 Head of Production and Head of Quality Control for ATP Manufacturers ............................ 11 Person-in-charge of Secondary Packaging ............................................................................. 13
8. Continuing Professional Development for Authorized Persons and Other Key Personnel ................................................................................... 14
CPD Training for APs ................................................................................................................ 14 CPD Training for Head of Production and Head of Quality Control ...................................... 15 CPD Training for Person-in-charge of Secondary Packaging ................................................ 15 Approved CPD Training ............................................................................................................ 16
Annex A: Knowledge Requirements for Authorized Person ............................... 17
Annex B: Explanatory Notes for Recognition of a Course for Registration as Authorized Person of Pharmaceutical Manufacturers ........................... 24
Annex C: Continuing Professional Development Training Programme for Authorized Persons and Other Key Personnel ............................................ 26
Annex D: Criteria for Recognition of a Certified GMP Training for Authorized Persons (i.e. Quality Assurance Officers) and Persons-in-charge of Secondary Packaging Manufacturers ......................................... 31
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 3
Licensed Manufacturers in Hong Kong
1. Background
1.1 The GMP Guides issued by the Pharmacy and Poisons Board (“the Board”) for Licensed
Manufacturers of pharmaceutical products (“Pharmaceutical Manufacturers”) and those carrying out only
secondary packaging of pharmaceutical products (“Secondary Packaging Manufacturers”) respectively
require that batches of pharmaceutical products should only be released for sale or supply after
certification by an Authorized Person (“AP”).
1.2 In addition, both GMP guides require that personnel must have the necessary qualifications and
practical experience to carry out their responsibilities, and manufacturers are responsible for providing
training for all personnel whose activities could affect the quality of the product.
1.3 To ensure these requirements are met, the AP and other key personnel must be suitably qualified,
experienced and competent for the types of manufacturing operations undertaken by the manufacturers
for whom he or she works.
1.4 Moreover, manufacturers and APs must ensure that training programmes as well as continuing
professional development (“CPD”) is part of the organisation’s culture.
1.5 Under the Pharmacy and Poisons Regulations (Cap. 138A), a Licensed Manufacturer must ensure
that at least one AP is employed to be responsible for ensuring and certifying that:
a. each batch of the pharmaceutical products has been manufactured and checked in
accordance with the GMP Guide; and
b. the registrable particulars of each batch of the pharmaceutical products correspond exactly
with the registered particulars of the products.
1.6 The stipulated requirements for registration as an AP are that:
a. the person is a registered pharmacist or holds a qualification awarded on completion of a
course recognized by the Pharmacy and Poisons (Manufacturers Licensing) Committee (“the
Committee”); and
b. the person has at least 3 years of relevant experience in Hong Kong or a place outside Hong
Kong in manufacturing pharmaceutical products in accordance with the GMP Guide or a
document similar or equivalent to that Guide issued or adopted by a competent authority of
a place outside Hong Kong; or meets any other criteria that the Committee may specify.
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 4
Licensed Manufacturers in Hong Kong
2. Purpose of this Guidance
2.1 This document outlines the requirements relating to the qualifications, experience and training
necessary for the APs and other key personnel working for manufacturers of pharmaceutical products in
Hong Kong.
3. Scope
3.1 This document applies to:
a. APs, Heads of Production and Heads of Quality Control of Pharmaceutical Manufacturers ;
b. APs, Heads of Production and Heads of Quality Control of Licensed Manufacturers of
advanced therapy products1 (“ATPs”); and
c. APs (i.e. Quality Assurance Officers) and Persons-in-charge of Secondary Packaging
Manufacturers.
1 The definition of advanced therapy product is set out in section 2 of the Pharmacy and Poisons Ordinance
(Cap.138).
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Licensed Manufacturers in Hong Kong
4. Authorized Person for Pharmaceutical Manufacturers
4.1 The scientific education and relevant experience of APs should be such as to enable them to
exercise independent professional judgement, on the basis of the application of scientific principles and
understanding to the practical problems encountered in the manufacture and quality control of
pharmaceutical products.
Registration as an AP for Pharmaceutical Manufacturers
4.2 An applicant applying for registration as an AP for Pharmaceutical Manufacturers should meet:
a. the qualification and experience requirements stipulated in 4.3 and 4.4 respectively; or
b. the requirements stipulated in 4.7.
Qualification and Experience Requirements
4.3 The applicant should either be:
a. a registered pharmacist; or
b. a holder of a qualification awarded on completion of a course recognized by the Committee—
i. In order for a course to be recognized by the Committee, the admission requirements
for the course should require the applicants to have a qualification in pharmacy,
medicine, veterinary medicine, pharmaceutical chemistry or technology, biology or
other related sciences, awarded on completion of a university course of study or a
course considered as equivalent by the Committee.
ii. The curriculum of the course should cover at least the knowledge requirements for APs
as stated in sections 1 to 7 of Annex A. If the curriculum of the course did not cover
the knowledge requirements stated in section 1 of Annex A, the applicant should
provide evidence that he or she has comprehensive knowledge on the pharmaceutical
law and administration in Hong Kong as stated in that section. Explanatory notes in
Annex B provide elaboration on the criteria for recognition of a course by the Committee.
4.4 The applicant, in addition to 4.3, should possess relevant practical experience—
a. at least 3 years of relevant experience at managerial or supervisory level in GMP
pharmaceutical manufacturing in one or more pharmaceutical manufacturers; and/or
b. at least 3 years of relevant experience at managerial or supervisory level in quality control in
one or more pharmaceutical manufacturers.
4.5 The relevant experience must have been undertaken in Hong Kong or in a country or region where
the regulatory authority is a PIC/S Participating Authority.
4.6 The 3 years of relevant experience should include at least 1 year preparatory period (which is
preceded by at least 2 years of the relevant experience) during which the person is under the supervision
and professional guidance of a practising AP in Hong Kong and should assist in exercising the duties of
an AP. The applicant should provide evidence that he or she has gained such an experience.
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 6
Licensed Manufacturers in Hong Kong
Alternative Qualification and Experience Requirements
4.7 An applicant who has already been practising as an AP or equivalent positions in countries or
regions where the regulatory authority is a PIC/S Participating Authority should provide evidence to
demonstrate to the satisfaction of the Committee that his or her qualification and experience are
comparable to the requirements as stated in 4.3 and 4.4 respectively.
Additional Requirements for Release of Pharmaceutical Products Requiring Special
Attention
4.8 An AP employed for the release of pharmaceutical products requiring special attention should
provide evidence of relevant training and/or practical experience, so as to demonstrate to the satisfaction
of the Committee that he or she is suitably qualified, experienced and competent for the types of the
manufacturing operations undertaken by the Pharmaceutical Manufacturers for whom he or she works.
4.9 Additional requirements for some types of products that require special attention are listed below:
a. For sterile pharmaceutical products, the APs should receive relevant training and/or possess
relevant practical experience in sterile manufacturing.
b. For active pharmaceutical ingredients, the APs should possess qualification of training in
knowledge requirement as stated in section 8 of Annex A.
c. For investigational medicinal products, the APs should possess qualification of training in
knowledge requirement as stated in section 9 of Annex A.
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Licensed Manufacturers in Hong Kong
5. Authorized Person for Pharmaceutical Manufacturers of Advanced
Therapy Products
5.1 The scientific education and relevant experience of APs of Pharmaceutical Manufacturers of ATPs
(“ATP Manufacturers”) should be such as to enable them to exercise professional judgement, on the
basis of the application of scientific principles and their understanding to the practical problems
encountered in GMP manufacturing and quality control of ATPs.
Registration as an AP for ATP Manufacturers
5.2 An applicant applying for registration as an AP for ATP Manufacturers should meet the qualification
and experience requirements stipulated in 5.3 and 5.4, and any conditions the Committee thinks fit to
impose.
Qualification and Experience Requirements
5.3 The applicant should be:
a. a holder of a bachelor’s degree in a discipline such as biotechnology, biomedical engineering,
medical laboratory science or other similar disciplines with at least 3 years of working
experience at managerial or supervisory level in GMP manufacturing or quality control of
ATPs;
b. a holder of a postgraduate degree of science relevant to cell therapy, gene therapy,
regenerative medicines or tissue engineering, or other related sciences with at least 2 years
of working experience at managerial or supervisory level in GMP manufacturing or quality
control of ATPs;
c. a holder of a degree of doctor of philosophy (PhD) of science relevant to cell therapy, gene
therapy, regenerative medicines or tissue engineering, or other related sciences with at least
1 year of working experience at managerial or supervisory level in GMP manufacturing or
quality control of ATPs;
d. a person who has already been practicing as an AP or equivalent positions for ATP
manufacturers in a country or region where the regulatory authority is a PIC/S Participating
Authority; or
e. a holder of a degree of PhD of science relevant to cell therapy, gene therapy, regenerative
medicines or tissue engineering, or other related sciences with at least 2 years of post-
doctoral working experience in the processing or quality control of cells, genes and tissue
engineered products and with evidence of theoretical and practical training in GMP principles
related to ATP manufacturing, who in this case should be registered as the AP with additional
requirement stipulated in 5.6.
5.4 The applicant should also provide evidence that he or she has comprehensive knowledge on the
pharmaceutical law and administration in Hong Kong as stated in section 1 of Annex A.
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 8
Licensed Manufacturers in Hong Kong
Additional Requirements for Release of ATPs
5.5 An AP employed for the release of ATPs should:
a. provide evidence of relevant training and/or practical experience in sterile pharmaceutical
products, biological substances and products, active pharmaceutical ingredients, and/or
investigational medicinal products, in the case it may apply, so as to demonstrate to the
satisfaction of the Committee that he or she is suitably qualified, experienced and competent
for the types of the manufacturing operations undertaken by the manufacturer for whom he
or she works; and
b. meet any other criteria that the Committee may specify.
5.6 An AP registered with the qualification and experience as stated in 5.3(e) and employed for the
release of ATPs, in addition to 5.5, should demonstrate to the Committee—on the basis of application of
scientific principles and his or her understanding to the practical problems encountered in GMP
manufacturing and quality control of the ATPs—that he or she can exercise the duties as an AP for the
types of the manufacturing operations undertaken by the manufacturer of ATPs, with the collaboration
of:
a. one or more AP(s) registered for Pharmaceutical Manufacturers or AP(s) for ATP
Manufacturers that is registered with qualification and experience other than in 5.3(e); or
b. one or more person(s) who has already been practicing as an AP or equivalent positions in a
country or region where the regulatory authority is a PIC/S Participating Authority.
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Licensed Manufacturers in Hong Kong
6. Authorized Person for Secondary Packaging Manufacturers
6.1 The education and relevant experience of APs for Secondary Packaging Manufacturers (i.e. Quality
Assurance Officer) should be such as to enable them to exercise independent professional judgement,
on the basis of the application of relevant principles and understanding to the practical problems
encountered in the manufacture and quality control of pharmaceutical products.
Registration as an AP for Secondary Packaging Manufacturers (i.e. Quality Assurance
Officer)
6.2 An applicant applying for registration as an AP solely for secondary packaging operations (i.e.
Quality Assurance Officer) should meet the qualification and experience requirements stipulated in 6.3.
Qualification and Experience Requirements
6.3 The applicant should possess—
a. post-secondary qualification with 1 year of experience in GMP pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products;
b. post-secondary qualification with 6 months of experience in GMP pharmaceutical
manufacturing and/or secondary packaging of pharmaceutical products, together with a
certified GMP training;
c. secondary qualification with 2 years of experience in GMP pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products; or
d. secondary qualification with 1 year of experience in GMP pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products, together with a certified GMP
training.
6.4 The criteria for recognition of a certified GMP training for APs for Secondary Packaging
Manufacturers (i.e. Quality Assurance Officers) and Persons-in-charge of Secondary Packaging
Manufacturers are set out in Annex D.
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Licensed Manufacturers in Hong Kong
6.5 Secondary qualification means an attainment of–
a. Level 2 or equivalent or above in five subjects (including Chinese Language and English
Language) in the Hong Kong Diploma of Secondary Education Examination (HKDSEE), or
equivalent;
b. Level 2 / Grade E2 or above in five subjects (including Chinese Language and English
Language) in the Hong Kong Certificate of Education Examination (HKCEE), or equivalent; or
c. local accredited higher diploma, associate degree, diploma of foundation studies, diploma Yi
Jin, or equivalent.
6.6 For qualifications awarded by granting bodies outside Hong Kong, the Hong Kong Council for
Accreditation of Academic and Vocational Qualifications (HKCAAVQ) provides assessment services for the
general public, organisations, and government bureaux or departments. The HKCAAVQ offers a
professional opinion on whether the totality of the educational qualifications (i.e. the integrated learning
outcomes of the highest and terminal educational qualification) of an individual meets the standard of a
particular level of qualification in Hong Kong (http://www.hkcaavq.edu.hk/).
2 ‘Grade E’ in Chinese Language and English Language (Syllabus B) in the HKCEE before 2007 are accepted
administratively as comparable to ‘Level 2’ in Chinese Language and English Language in the 2007 HKCEE and
henceforth
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 11
Licensed Manufacturers in Hong Kong
7. Other Key Personnel
7.1 The education and relevant experience of Heads of Production and Heads of Quality Control should
be such as to enable them to exercise independent professional judgement, on the basis of the
application of relevant principles and understanding to the practical problems encountered in the
manufacture and quality control of pharmaceutical products.
Head of Production and Head of Quality Control for Pharmaceutical Manufacturers
Qualification and Experience Requirements
7.2 The Head of Production or Head of Quality Control for Pharmaceutical Manufacturers should be:
a. a holder of a bachelor's degree in pharmacy with at least 2 years relevant working experience
in GMP pharmaceutical manufacturing or quality control;
b. a holder of the Higher Diploma in Pharmaceutical Technology or of the Certificate in
Dispensing Studies awarded by the Vocational Training Council of Hong Kong (“VTC”), with
at least 3 years of relevant working experience in GMP pharmaceutical manufacturing or
quality control;
c. a holder of the Higher Diploma in Pharmaceutical Science (Technology and Management)
awarded by the VTC with at least 3 years of relevant working experience in GMP
pharmaceutical manufacturing or quality control3; or
d. a holder of a bachelor's degree in a relevant science discipline with at least 3 years of relevant
working experience in GMP pharmaceutical manufacturing or quality control.
Additional Requirements for Those Working for Manufacturers of Pharmaceutical Products Requiring
Special Attention
7.3 A Head of Production or a Head of Quality Control for manufacturers of pharmaceutical products
that require special attention (e.g. sterile products) should provide evidence of relevant training and/or
practical experience, so as to demonstrate to the satisfaction of the Committee that he or she is suitably
qualified, experienced and competent for the types of manufacturing and quality control operations
undertaken by the manufacturers for whom he or she works.
Head of Production and Head of Quality Control for ATP Manufacturers
7.4 The Head of Production and Head of Quality Control for ATP Manufacturers should meet the
qualification and experience requirements stipulated in 7.5 and 7.6.
3Graduates of this course in the year 2014 are required to provide an additional "Certificate in Pharmaceutical
Science (Pharmaceutical Microbiology Module)" awarded by the VTC
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Licensed Manufacturers in Hong Kong
Qualification and Experience Requirements
7.5 The Head of Production or Head of Quality Control for ATP Manufacturers should be—
a. a holder of a bachelor’s degree in a discipline such as biotechnology, biomedical engineering,
medical laboratory science and other similar disciplines with at least 3 years of working
experience at managerial or supervisory level in GMP manufacturing or quality control of
ATPs;
b. a holder of a postgraduate degree of science relevant to cell therapy, gene therapy,
regenerative medicines or tissue engineering, or other similar sciences with at least 2 years
of working experience at managerial or supervisory level in GMP manufacturing or quality
control of ATPs;
c. a holder of a degree of PhD of science relevant to cell therapy, gene therapy, regenerative
medicines or tissue engineering, or other related sciences with at least 1 year of working
experience at managerial or supervisory level in GMP manufacturing or quality control of
ATPs; or
d. a holder of a degree of PhD of science relevant to cell therapy, gene therapy, regenerative
medicines or tissue engineering, or other related sciences with at least 2 years of post-
doctoral working experience in the processing or quality control of cells, genes and tissue
engineered products and with evidence of theoretical and practical training in GMP principles
related to ATP manufacturing.
7.6 The Head of Production or Head of Quality Control for ATP Manufacturers should provide evidence
that he or she received relevant training and/or possess practical experience in sterile pharmaceutical
products, biological substances and products, active pharmaceutical ingredients, and/or investigational
medicinal products, in the case it may apply, so as to demonstrate to the satisfaction of the Committee
that he or she is suitably qualified, experienced and competent for the types of manufacturing operations
undertaken by the manufacturers for whom he or she works.
The Head of Production or the Head of Quality Control Performing the Role of AP
7.7 The same person can perform the role of Head of Quality Control and the AP of ATP Manufacturers.
It is also possible for the AP to be responsible for production. However, responsibility of the Head of
Production and the Head of Quality Control cannot be assumed by the same person.
7.8 In manufacturers with small organization where personnel are multi-skilled and trained in both
production and quality control activities, it may be acceptable that the same person is responsible for
both roles with respect to different batches. For any given batch, the responsibility for production and
quality control of the batch must be vested on two different persons. Accordingly, it becomes particularly
important that the independency of the quality control activities from the production activities for the
same batch is clearly established through appropriate written procedures.
Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Page 13
Licensed Manufacturers in Hong Kong
Person-in-charge of Secondary Packaging
Qualification and Experience Requirements
7.9 The Person-in-charge of Secondary Packaging should possess:
a. post-secondary qualification with 1 year of experience in GMP Pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products;
b. post-secondary qualification with 6 months of experience in GMP Pharmaceutical
manufacturing and/or secondary packaging of pharmaceutical products, together with a
certified GMP training.
c. secondary qualification with 2 years of experience in GMP Pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products; or
d. secondary qualification with 1 year of experience in GMP Pharmaceutical manufacturing
and/or secondary packaging of pharmaceutical products, together with a certified GMP
training.
7.10 Details of the certified GMP training and meaning of ‘secondary qualification’ are set out in Annex
D and section 6.5 respectively.
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Licensed Manufacturers in Hong Kong
8. Continuing Professional Development for Authorized Persons and
Other Key Personnel
8.1 The continuing professional development (“CPD”) training programme for APs and other key
personnel of Licensed Manufacturers is to ensure that they continue to possess up-to-date knowledge
and skills with a view to maintain quality professional practice. Under the programme, key personnel
should undertake CPD training every year on topics relevant to their role and duties.
CPD Training for APs
8.2 In order to renew his or her registration each year, a registered AP must provide evidence that he
or she has undertaken CPD training at courses, seminars, webinars or any other form of training approved
by the Committee for—
a. at least 20 hours per year or equivalent for an AP for Pharmaceutical Manufacturers, including
APs for ATP Manufacturers; or
b. at least 7 hours per year or equivalent for an AP solely for Secondary Packaging
Manufacturers (i.e. a Quality Assurance Officer).
8.3 A registered AP should fulfill the requirements every year for a period from 1 December of the
previous year to 30 November of the current year in order for their registration to be renewed in January
annually. For example, to renew the registration in January 2022, registered AP should fulfill and
complete the required CPD training within the period from 1 December 2020 to 30 November 2021.
Details of requirements are set out in Annex C.
8.4 Examples of CPD training topics relevant to the role and duties of AP for Pharmaceutical
Manufacturers include:
a. Role and professional duties of an AP
b. Quality management systems
c. Quality risk management
d. Qualification & validation
e. PIC/S GMP Guide and Annexes
f. Pharmaceutical manufacturing or technology
g. Pharmaceutical packaging
h. Warehousing
i. Pharmaceutical microbiology
j. Sampling, analysis and testing of pharmaceuticals
k. Active pharmaceutical ingredients
l. Mathematics and statistics related to pharmaceuticals
m. Registration of pharmaceutical products
8.5 Examples of CPD training topics relevant to the role and duties of AP for Secondary Packaging
Manufacturers (i.e. Quality Assurance Officer) include:
a. Pharmaceutical law and administration in Hong Kong
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b. Role and professional duties of an AP
c. Quality management systems
d. Quality risk management
e. PIC/S GMP Guide and Annexes
f. Pharmaceutical packaging
g. Warehousing
h. Registration of pharmaceutical products
CPD Training for Head of Production and Head of Quality Control
8.6 The Head of Production or Quality Control for Pharmaceutical Manufacturers, including heads for
ATP Manufacturers, who does not perform the role of AP should undertake at least 14 hours per year or
equivalent of CPD training on topics relevant to his or her role and duties. He or she should maintain
records of this training for review by inspectors during GMP inspections. The CPD requirements will be
implemented at a later stage as determined by the Committee.
8.7 Examples of CPD training topics relevant to the role and duties of Head of Production or Quality
Control include:
a. Quality management systems
b. Quality risk management
c. Qualification & validation
d. PIC/S GMP Guide and Annexes
e. Pharmaceutical manufacturing or technology
f. Pharmaceutical packaging
g. Warehousing
h. Pharmaceutical microbiology
i. Sampling, analysis and testing of pharmaceuticals
CPD Training for Person-in-charge of Secondary Packaging
8.8 The Person-in-charge of Secondary Packaging should undertake at least 7 hours per year or
equivalent of CPD training on topics relevant to his or her role and duties. He or she should maintain
records of this training for review by inspectors during GMP inspections. The CPD requirements will be
implemented at a later stage as determined by the Committee.
8.9 Examples of CPD training topics relevant to the role and duties of Person-in-charge of Secondary
Packaging include:
a. Quality management systems
b. Quality risk management
c. PIC/S GMP Guide and Annexes
d. Pharmaceutical packaging
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Licensed Manufacturers in Hong Kong
e. Warehousing
Approved CPD Training
8.10 The CPD training activities and their providers should be assessed and approved by the Committee.
A list of approved CPD training activities and their providers is available on the websites of the Board
and Drug Office. The list will be updated periodically.
8.11 For those CPD training activities organised by other training providers (i.e. activities and/or their
providers not recognized by the Committee yet), APs or those training providers should submit application,
via the Drug Office, to the Committee for approval. For details, please refer to Annex C.
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Licensed Manufacturers in Hong Kong
Annex A: Knowledge Requirements for Authorized Person
1. Pharmaceutical Law and Administration in Hong Kong
1.1 The AP, in particular, must ensure that all legislative obligations are fully satisfied before any
product is released for sale or supply.
1.2 An AP must have comprehensive knowledge of all Hong Kong legislation relating to the
registration, manufacture, storage and supply of pharmaceutical products and should have a thorough
understanding of the following:
a. Registration of pharmaceutical products, manufacturing and wholesaler licensing / approval
structure, content, application and approval procedures, and responsibilities;
b. Role, legal status and structure of the relevant pharmacopoeia requirements in Hong Kong;
c. Procedures for dealing with complaints and product recalls, the role of the defect reporting
process in Hong Kong; and
d. How to interpret and apply the regulations concerning importation and exportation of
pharmaceutical products in Hong Kong.
2. The Role and Professional Duties of an AP
2.1 It is incumbent upon all APs that they discharge their professional duties in accordance with the
Code of Practice for Hong Kong Licensed Manufacturers and Registered Authorized Persons.
2.2 It is the responsibility of the AP to certify that a product has been manufactured or packaged in
compliance with the requirements of the current GMP guide issued by the Board in respect of
pharmaceutical products and the registrable particulars correspond with the registered particulars
for the products.
2.3 The AP must be aware of any information, incidents or deviations which may influence their
decision to certify whether a batch is suitable for release for sale or supply.
2.4 APs should have a thorough understanding of the following:
a. The routine legal duties of an AP, the level of oversight required; including detailed
knowledge on the principles and application of ‘quality risk management’ within the
pharmaceutical industry;
b. Batch review and decision making on disposition of batches of pharmaceutical products, i.e.
whether to release for sale or supply; or in the case of non-compliant or defective material
to decide on its rejection, rework orreprocessing;
c. The key factors, information or metrics that confirm a batch of pharmaceutical product has
a suitable pedigree demonstrated throughout the manufacturing supply chain and has been
manufactured according to current PIC/S GMP requirements;
d. The principles and practice of current GMP and quality assurance (“QA”) as given in the
current PIC/S Guide to GMP, including related Hong Kong legislation;
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Licensed Manufacturers in Hong Kong
e. The conduct and obligations of holders of a manufacturer licence and registration certificates
for pharmaceutical products;
f. The preparation for and management of regulatory GMP inspections;
g. The tools and methods used for risk management and their interface with regulatory
requirements; and
h. The requirements for APs when acting as independent contractors or on behalf of third parties.
3. Quality Management Systems
3.1 The manufacture of pharmaceutical products requires the establishment and implementation of
an effective ‘quality management system’ (“QMS”). The basic concepts of QA, GMP, quality control (“QC”)
and quality risk management, which are inter-related, form the basis of such a system for the
manufacture of pharmaceutical products from initial development, through clinical phases to commercial
supply.
3.2 APs must have a thorough understanding of the following:
a. The philosophy and basic principles of QA;
b. The design criteria for an effective QMS including but not limited to;
i. auditing and self-inspections;
ii. management of quality and GMP at approved vendors and contractors;
iii. deviations, root cause analysis, corrective and preventive actions;
iv. change control;
v. documentation and record keeping;
vi. quality risk management;
vii. complaints and recalls; the interpersonal skills (leadership, delegation, communication,
etc.) necessary to implement an effective QMS;
c. The interpersonal skills (leadership, delegation, communication, etc.) necessary to implement
an effective QMS;
d. The principles of design, selection, qualification and maintenance of premises, equipment,
utilities, and services;
e. Calibration, preventative maintenance and training;
f. The principles of purchasing and supplier certification, including knowledge of supply chains
and material control including but not limited to:
i. the roles of brokers, distributors and repackers;
ii. prevention of counterfeiting and illegal activities;
iii. processes to support and verify the supply chain pedigree;
iv. monitoring and control of both product and raw material transport and distribution
processes.
g. Production planning, scheduling, and inventory control;
h. Product quality reviews;
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i. The interface between QA and the planning, production, quality control, purchasing,
pharmaceutical development, regulatory affairs, medical, pharmacovigilance and marketing
departments;
j. The skills and competences needed to provide effective Good Pharmaceutical Manufacturing
Practice training;
k. Organizational structures and reporting relationships;
l. Technical agreements and auditing in contract giving and acceptance.
4. Pharmaceutical Formulation and Processing
4.1 The formulation and processing conditions employed in the manufacture of pharmaceutical
products have a significant effect upon their safety, quality and efficacy. Even subtle changes to the
input materials and/or processing conditions can have a profound adverse effect on content uniformity,
stability, bioavailability, and other attributes which are not detectable by routine QC testing.
4.2 It is vitally important that the AP understands the principles of formulation and pharmaceutical
processing to ensure that informed release decisions are made.
4.3 APs must have a good understanding of the following:
a. The major processing techniques, their limitations and critical control parameters;
b. The factors that could potentially affect purity, content uniformity, stability (chemical,
physical and microbiological) and bioavailability in manufacture;
c. The principles of process validation and control;
d. The principles of technology transfer and production scale-up;
e. Pre-formulation studies and product development; and
f. The storage and distribution of materials and finished products.
5. Pharmaceutical Microbiology
5.1 The AP must understand the significance of the presence of bacteria, yeasts, moulds, viruses and
toxins in pharmaceutical starting materials, products and production environments. In addition, they
must understand how to prevent contamination through good product and facility design, GMP and
control over starting materials, intermediates, finished products, production plant and processes, people
and the environment.
5.2 APs must have a good understanding of the following:
a. Sources and types of micro-organisms as related to pharmaceutical production;
b. Production of sterile and non-sterile products and associated environmental controls;
c. Bacterial endotoxins and pyrogens, their sources, removal and testing;
d. Microbiology of water, its production and distribution systems; including different grades of
water, their use, manufacture and control;
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e. Sterilization and disinfection methods;
f. Interpretation of microbiological data;
g. Validation of microbiological test methods;
h. Microbiological specifications;
i. Selection and use of preservatives;
j. Microbiological test methods used in routine manufacture and product development; and
k. Rapid methods of microbiological testing.
6. Analysis and Testing
6.1 The sampling and testing of materials does not by itself assure product quality. It must be seen
as one part of a comprehensive QMS, including QA and GMP, which must be correctly implemented and
controlled.
6.2 The data generated by laboratory testing of samples must be evaluated before materials are
released for sale or supply.
6.3 APs must have a good understanding of the following:
a. Good Control Laboratory Practice;
b. The underlying principles of and interpretation of qualitative and quantitative analytical
methods in common use for the analysis of medicinal products;
c. The underlying principles, application and interpretation of biological analytical test methods
and validation;
d. The underlying principles, application and interpretation of analytical method selection and
validation;
e. The underlying principles, application and interpretation of stability testing (protocols and
methods), used during development to determine product shelf life and support ongoing
marketing of the product;
f. The significance of degradation, contamination and adulteration of pharmaceutical materials;
g. The underlying principles, methods and types, purpose, significance and management of
systems of in-process control;
h. The underlying principles, application and design of sampling regimes;
i. The underlying principles, application and design of analytical method transfers;
j. The International Conference on Harmonisation guidelines for method validation, impurities
and stability testing;
k. “Out-of-specification” results and systems or procedures for monitoring and control; and
l. Sample retention and retesting.
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7. Pharmaceutical Packaging
7.1 It is a requirement of GMP that holders of manufacturing licences establish procedures for their
packaging operations to minimise the risk of cross-contamination, mix-up or substitutions. The AP must
understand the importance of controlling packaging components (both primary and printed materials)
throughout the supply chain to assure the quality of finished products.
7.2 APs must have a good understanding of the following:
a. Control of packaging components by suppliers and throughout production;
b. The chain of systems which ensure the integrity and accuracy of textual information from
originator to routine production, including artwork generation, text approvals and regulatory
submission requirements;
c. The testing of packaging materials as part of incoming goods checks, including the application
of sampling regimes and vendor assurance programmes;
d. The potential root causes of label and other printed component mix-ups and how they can
be identified and eliminated;
e. The optimum layout, organization and control of packaging operations, different types of
packaging and labelling processes and equipment, including the consideration of the type of
equipment required for high volume or high speed operations and smaller or manual
operations;
f. The underlying principles and application of in-process controls conducted during packaging
operations, including line clearance, pack integrity testing, challenge testing, reconciliation,
bar coding and optical systems;
g. The design and completion of packaging batch records, including full traceability of all
products and materials for investigation and recall purposes;
h. Effects of packaging materials on product stability; and
i. The requirements and desirability of tamper-evidence, anti-counterfeiting and general supply
chain security.
8. Active Pharmaceutical Ingredients
8.1 The AP working for an active pharmaceutical ingredients (“APIs”) manufacturer must understand
the influence of manufacturing pathways and associated physical and physico-chemical attributes, of
both active pharmaceutical ingredients and major excipients on the quality of the finished dosage form.
8.2 APs working for API manufacturers must have a good understanding of the following:
a. The steps commonly taken in the manufacture of APIs and excipients including their purpose
and limitations;
b. The requirements of Part II of the PIC/S Guide to GMP as applied to the production of APIs;
c. The pathways responsible for the generation of impurities or degradation products, analytical
methods for their identification, quantification, and possible strategies for elimination of such
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impurities;
d. The potential and avoidance of contamination and adulteration of API and verification of the
supply chain pedigree;
e. The physico-chemical and biological properties of APIs and excipients, and their effect on the
attributes of the final dosage form;
f. The requirements for APIs intended for use in sterile products;
g. The principles and technical requirements for the manufacture and control of bulk biological,
herbal and biotech products; and
h. API audit and certification requirements.
9. Investigational Medicinal Products
9.1 The manufacture, packaging and distribution of investigational medicinal products (“IMPs”) must
be controlled. There are significant differences between the manufacture and packaging of IMPs and
licensed dosage forms. The AP must understand these differences together with the safeguards required
to assure the quality of IMP supply.
9.2 APs involved in the manufacture, packaging and distribution of IMPs must have a good
understanding of the following:
a. The application and interpretation of specific GMPs associated with the manufacture of IMPs;
b. The underlying principles and application of the manufacture and control, the expectations
around the level of validation required for each phase of development, including those for
analytical methods and those processes, equipment and tests essential to assure the safety
and quality of the products;
c. The underlying principles and application of the control of packaging operations including
blinding and associated controls;
d. The requirements for effective batch documentation, control, sampling, testing and batch
release or certification, including the control and release of imported IMPs, comparators from
other countries;
e. Change control and material traceability;
f. Controls surrounding the procurement, storage, distribution and control of IMPs, non-IMPs,
placebo and licensed and un-licensed comparators;
g. The underlying principles, application and interpretation of Good Clinical Practice;
h. An appreciation of the Declaration of Helsinki;
i. The requirements for the content, management, control and application of the product
registration file;
j. The structure and contents of the application of clinical trial certificate;
k. Clinical trial design at all phases (I, II, III and IV), including early stage safety and dose
ranging studies through to post marketing studies;
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l. The requirements for specific dosage forms and drug types; and
m. Safety management for clinical trials, including pharmacovigilance and associated reporting
requirements.
Note: For the definition of IMP, please refer to the Annex 13 of the PIC/S Guide to GMP.
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Annex B: Explanatory Notes for Recognition of a Course for Registration as Authorized Person of Pharmaceutical Manufacturers
1. Introduction
1.1 Regulation 30C of the Pharmacy and Poisons Regulations (Chapter 138A) stipulates that an applicant for registration as an AP could be a registered pharmacist or a holder of a qualification awarded on completion of a course which was recognized by the Committee.
1.2 This paper provides additional information for course providers and applicants for registration as AP when submitting applications for recognition of a course for registration as an AP of Pharmaceutical Manufacturers by the Committee. This does not apply to an AP of a manufacturer solely engaged in secondary packaging operations or in the manufacture of ATPs.
2. Course Requirements
2.1 In order for a course to be recognized by the Committee, it must meet established professional qualifications and educational standards. The goals and objectives of the course should embrace the scope of contemporary practice responsibilities of APs in Pharmaceutical Manufacturers as well as the emerging roles that ensure the production, control and release of products complying GMP requirements.
2.2 The course provider should demonstrate that it has the abilities and capacities to effectively manage the quality of the course, and the course meets the required standards to achieve its claimed objectives and deliver the intended learning outcomes. The criteria which the Committee must consider in recognition of the course include but not limited to the followings:
2.2.1 Course providers
2.2.1.1 The course should be organized by a university that has an academic mission towards research and other scholarly activities.
2.2.2 Students admissions
2.2.2.1 The admission requirements for the course should require the applicant to have a qualification in pharmacy, medicine, veterinary medicine, pharmaceutical chemistry or technology, biology or other related sciences awarded on completion of a university course of study or a course considered as equivalent by the Committee.
2.2.3 Academic program
2.2.3.1 General course design
2.2.3.1.1 The course should, on completion, award an accredited master degree. The duration of the course should be at least one year for a full-time course or two years for a part-time course or in equivalent hours in core theoretical teaching and practical tuition. The mode of teaching can be face-to-face classroom teaching or distance learning.
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2.2.3.1.2 Alternatively, the course should have been recognized by a PIC/S Participating Authority as educational requirements for practice as an AP or equivalent positions in that country or region.
2.2.3.2 Course curriculum (knowledge and skills)
2.2.3.2.1 The curriculum of the course should cover at least the following topics for the knowledge requirements for APs:
a. Pharmaceutical law and administration in Hong Kong
b. The role and professional duties of AP
c. Quality management systems
d. Pharmaceutical formulation and processing
e. Pharmaceutical microbiology
f. Analysis and testing
g. Pharmaceutical packaging
(For details, please refer to sections 1-7 in Annex A of the Guidance on Qualification, Experience and Training Requirements for Authorized Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong).
2.2.3.3 Course assessment
2.2.3.3.1 To assess the student learning and progression, the assessment instruments of the course should be reliable and valid.
3. Application submission
3.1 There is no prescribed form for the application. The application must be made in writing by the course provider or an applicant applying for registration as AP. The application letter with the course portfolio and the documentary proof which the course fulfils the criteria set above should be submitted to the Drug Office, Department of Health.
Licensing and Compliance Division, Monday to Friday Drug Office, Department of Health 9:00 am to 1:00 pm Room 2550, 2:00 pm to 5:45 pm 25/F Wu Chung House, (up to 6:00 pm on Monday) 213 Queen’s Road East, (Closed on Saturdays, Sundays and Public Holidays) Wan Chai, Hong Kong
Tel: 2961 8162 Fax.: 3904 1225 Email: [email protected]
Note: A meeting with the course provider may be held. The course provider should present specific information about the course as requested by the Committee.
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Annex C: Continuing Professional Development Training Programme for
Authorized Persons and Other Key Personnel
1. Introduction
1.1 The objective of the continuing professional development (“CPD”) training programme for
registered APs and other key personnel of Licensed Manufacturers is to ensure that they continue to
possess up-to-date knowledge and skills in pharmaceutical quality management, regulatory aspects and
GMP standards, product manufacturing and control technology, and general work practices with a view
to maintain quality professional practice.
2. CPD Requirements
2.1 Key Personnel for Pharmaceutical Manufacturers
2.1.1 To renew the registration as an AP for Pharmaceutical Manufacturers including an AP for
ATP Manufacturers each year, every AP must provide evidence that he or she has
undertaken at least 20 hours per year or equivalent of CPD training at courses, seminars
or any other form of training approved by the Committee.
2.1.2 The Heads of Production and Quality Control are encouraged to undertake at least 14
hours per year or equivalent of CPD training on topics relevant to their role and duties on
self-regulatory and voluntary basis.
2.2 Key Personnel for Secondary Packaging Manufacturers
2.2.1 To renew the registration as an AP for Secondary Packaging Manufacturers (also known
as Quality Assurance Officer) each year, the Quality Assurance Officer must provide
evidence that he or she has undertaken at least 7 hours per year or equivalent of CPD
training at courses, seminars or any other form of training approved by the Committee.
2.2.2 The Person-in-charge of Secondary Packaging are encouraged to undertake at least 7
hours per year or equivalent of CPD training on topics relevant to their role and duties on
self-regulatory and voluntary basis.
3. Calculation of CPD Hours
3.1 A CPD year is a period of 12 months starting from 1 December of the previous year to 30
November of the current year. In general, one CPD hour is considered to be equivalent to one hour
spent on the CPD training, subject to the approval of the Committee.
3.2 New APs and other new key personnel are required to complete their CPD requirements on a pro-
rata basis.
3.3 It is the AP’s and other key personnel’s responsibilities to record and calculate how many CPD
hours have taken place. Any excess CPD hours accumulated within a particular CPD year cannot be
carried forward to any other CPD years.
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3.4 A list of approved CPD training programmes and the respective CPD hours allocated by the
Committee will be available and periodically updated on the websites of the Board and the Drug Office.
4. Details of the CPD Training Programme
4.1 CPD training programme is divided into two Category 1 and Category 2 CPD activities. Category
1 CPD training is defined as an activity that has been evaluated and approved by the Committee.
Category 2 CPD training is defined as a learning activity that is relevant to the role and duties of the
trainee and may enhance the current competency of or instil new knowledge or skills into the trainee.
Those activities may not be approved by the Committee.
4.2 The CPD requirements for different groups of personnel are as follows:
4.2.1 The registered APs should complete at least 20 hours per CPD year of Category 1 CPD
activities while Quality Assurance Officers should complete at least 7 hours per CPD year
of Category 1 CPD activities to fulfil their CPD requirements. APs and Quality Assurance
Officers are also encouraged to participate in Category 2 activities.
4.2.2 Other key personnel (including Heads of Production or Quality Control of Pharmaceutical
Manufacturers and Persons-in-charge of Secondary Packaging) are encouraged to
participate in either Category 1 or Category 2 CPD trainings to fulfil their CPD requirements.
The CPD requirement for Heads of Production or Quality Control of Licensed Manufacturers
is at least 14 hours per CPD year or equivalent while the Persons-in-Charge of Secondary
Packaging was 7 hours per CPD year or equivalent.
Table 1. CPD Requirements for Different Groups of Personnel
Hours of activities required to attend per CPD year
Category 1 activities Category 2 activities
The registered APs 20 hours Encouraged
Quality Assurance Officers 7 hours Encouraged
Heads of Production Encouraged 14 hours of either Category 1 or 2 activities
Heads of Quality Control Encouraged 14 hours of either Category 1 or 2 activities
Persons-in-charge of secondary packaging
Encouraged 7 hours of either Category 1 or 2 activities
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4.2.3 Examples of Category 1 and Category 2 CPD Activities are as follows:
Table 2. Category 1 Activities
Item Description of Activity
1A Attending a lecture, a course, a seminar or a webinar recognised by the Committee
1B Presenting at or attending conferences or professional meetings recognised by the
Committee
1C Reading reference materials prescribed by the Committee
The date, time spent and reference materials read should be noted in a personal logbook.
1D Writing for publication on relevant GMP topics (e.g. journal articles, books, education
materials)
1E Teaching a programme on relevant GMP topics approved by the Committee
Repeated presentation of the same materials will not be counted as CPD activity unless the repeated work entails updating of the presentation material. In this case only the time spent on research and
updating the material should be counted as CPD hours.
Table 3. Category 2 Activities
Item Description of Activity
2A Attending a lecture, a course, a seminar, a webinar or a conference
2B Participating in a professional reading and discussion group (e.g. in-house training, a
journal club, invited talks and presentations)
2C Reading professional journals or books
The date, time spent and literature read should be noted in a personal logbook.
2D Audio-visual viewing / Information technology / Printed media
Non-assessed audio / videotapes and information technology accessed via printed or electronic media
(such as CD ROMs, the internet, etc.), either used privately by individuals or in a discussion group.
Notes:
1. Normal work activities carried out (e.g. lectures, presentations, researches or teaching
and learning activities) as part of or wholly the AP’s or key personnel’s duties would not be awarded
any CPD hours.
2. Reading, reviewing and writing reference materials, professional journals or books could
claim a maximum of 6 CPD hours per year in Category 1 and/or Category 2 for key personnel for
Pharmaceutical Manufacturers and 3 CPD hours per year in Category 1 and/or Category 2 for key
personnel for Secondary Packaging Manufacturers.
3. Repeated attendance of a CPD activity of the same level on the same topic within two
years would not be awarded any CPD hours.
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5. Recognition of CPD training activities
5.1 To apply for recognition of CPD training, training providers should demonstrate their management
capabilities in respect of CPD training programme. To this end, training providers should submit the
following documents to the Committee for assessment:
5.1.1 Organizational management, including accreditation status, policy, quality assurance, and
operational framework, etc.;
5.1.2 Physical resources;
5.1.3 Staffing, including qualification of teaching staff and experience in the field;
5.1.4 Pre-requisite and admission requirements;
5.1.5 Teaching methodology and learning objectives;
5.1.6 Assessment of the training effectiveness;
5.1.7 Record and information management;
5.1.8 Detailed programme structure and content (suggested CPD training topics are outlined in
section 8 of the Guidance on Qualification, Experience and Training Requirements for
Authorized Persons and other Key Personnel of Licensed Manufacturers in Hong Kong);
and
5.1.9 Other information required by the Committee.
6. CPD Record Keeping
6.1 It is the AP’s and other key personnel’s responsibilities to maintain their CPD training records and
the respective supporting documents for review upon request. When and as requested by the Committee,
AP or Quality Assurance Officer must provide their CPD training records together with supporting
documents within the appointed time. For auditing purposes, the CPD training records should be retained
for at least 2 years after the period to which they relate. A CPD record sheet template is provided in
Appendix 1.
6.2 CPD training is also a requirement for renewing the AP and Quality Assurance Officer registration.
For renewal of registration, APs and Quality Assurance Officers should submit their completed CPD record
sheets together with the Application Form for Renewal of Registration as Authorized Person to the Drug
Office 1 month prior to expiry of the registration certificate submitted to the Drug Office, Department of
Health.
Licensing and Compliance Division
Drug Office, Department of Health
Rm 2550, 25/F Wu Chung House,
213 Queen’s Road East, Wanchai, Hong Kong
Tel: 2961 8162 Fax: 3904 1225
Email: [email protected]
Monday to Friday
9:00 am to 1:00 pm
2:00 pm to 5:45 pm
(up to 6:00 pm on Monday)
(Closed on Saturdays, Sundays and Public
Holidays)
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Appendix 1
Continuing Professional Development (CPD) Record Form
CPD Record Form for 1 December ______ to 30 November ______
Name: ___________________________________ Post: _______________________________
CPD Activities Training Provider & Title Time
Period
CPD Hours
Category 1 Category 2
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
Total CPD Hours:
I certify that the information provided is true and correct; the CPD training courses listed above have not been repeatedly attended in previous 24 months.
Signature:__________________________________________
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Annex D: Criteria for Recognition of a Certified GMP Training for
Authorized Persons (i.e. Quality Assurance Officers) and Persons-in-
charge of Secondary Packaging Manufacturers
1. Introduction
1.1 According to the Guidance on Qualification, Experience and Training Requirements for Authorized
Persons and Other Key Personnel of Licensed Manufacturers in Hong Kong, a person having post-
secondary qualification applying for registration as an AP solely for secondary packaging operations (i.e.
a Quality Assurance Officer) or a Person-in-charge in Secondary Packaging has to provide evidence
showing that they obtain 1 year of experience in GMP pharmaceutical manufacturing and/or secondary
packaging of pharmaceutical products; or 6 months of above experience together with a certified GMP
training. For applicants with secondary qualification, he or she should have 2 years of experience in GMP
pharmaceutical manufacturing and/or secondary packaging of pharmaceutical products; or 1 year of
above experience together with a certified GMP training.
1.2 This paper outlines the criteria for recognition of a certified GMP training for the Quality Assurance
Officer and Person-in-charge of Secondary Packaging in Hong Kong.
2. Criteria for Recognition
2.1 Training providers
2.1.1 The training providers should demonstrate their management capabilities in respect of the
implementation of a certified GMP training.
2.2 Staff qualification
2.2.1 The trainers should be specialized in the field of pharmaceutical manufacturing or secondary
packaging of pharmaceutical products and that he or she has experience in the packaging
development, testing, legislation and project management across applications.
2.3 Course design
2.3.1 A certified GMP training should cover the skills and knowledge which apply to the needs
and professional standards of Quality Assurance Officer and Person-in-charge of Secondary
Packaging, including but not limited to:
a. Pharmaceutical law and administration in Hong Kong;
b. The role and professional duties of Quality Assurance Officer and Person-in-charge of
Secondary Packaging;
c. The Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products;
d. Code of Practice for Licensed Manufacturers and Registered Authorized Persons; and
e. Other guidance(s) for industry issued by the Drug Office (if applicable).
2.4 Mode of teaching
2.4.1 A minimum of 14 hours of classroom instruction with oral or written assessments is required
for recognition of a certified GMP training. A Certificate of Completion should only be issued
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upon fulfilling attendance requirement of 90% or above and satisfactorily completing all
required assessments.
3. Application Submission
3.1 There is no prescribed form for the application. The application must be made in writing by the
course provider, the application letter with the course portfolio and the documentary proof which the
course fulfils the criteria set above should be submitted to the Drug Office, Department of Health.
Licensing and Compliance Division, Monday to Friday
Drug Office, Department of Health 9:00 am to 1:00 pm
Rm 2550, 2:00 pm to 5:45 pm
25/F Wu Chung House, (up to 6:00 pm on Monday)
213 Queen’s Road East, (Closed on Saturdays, Sundays and Public Holidays)
Wanchai, Hong Kong
Tel: 2961 8162 Fax: 3904 1225
Email: [email protected]
Note: A meeting with the course provider may be held. The course provider should present specific
information about the course as request by the Committee.
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Document Information
Version Date Description of Change
1.0 May 2015 First version
2.0 Apr 2018 Update on the requirements and implementation details for the CPD
3.0 Sep 2018 Revision of the scope and addition of qualification, experience and training
requirements for AP and other key personnel for ATP manufacturers.
Addition of explanatory notes for recognition of a course for registration as AP.
4.0 Jul 2019 Addition of a new category under the qualification and experience
requirements of AP for ATP manufacturers and other key personnel for ATP
manufacturers.
Addition of a new mode of collaboration under the additional requirements for
release of ATPs of AP for ATP manufacturers.
Re-organization of the outline of the document and grouping of the CPD for
AP and other key personnel under an individual section.
4.1 Oct 2019 Update on the definitions of ATP according to the Pharmacy and Poisons
(Amendment) Bill 2019 of Gazette (18 Oct 2019).
Addition of document information.
4.2 Dec 2019 Update on the name of “Traders Licensing & Compliance Division” to “Licensing
& Compliance Division”.
4.3 Jun 2021 Deletion of the Annex on proposed definitions of ATPs.
Update on the implementation of CPD requirements.
Textual alignments with the “Code of Practice for Licensed Manufacturers and
Registered Authorized Persons” and Regulation 30A of the Pharmacy and
Poions Regulations, Cap. 138A.
DOCUMENT END